Summary

This clinical trial studies image-guided adaptive radiotherapy in detecting tumors during
treatment in patients with head and neck cancer. Image-guided adaptive radiotherapy uses
high quality imaging technology to detect the tumor and normal organs during treatment. It
is not yet known which imaging technique provides the best image for guidance during
treatment with radiation therapy. Comparing results of imaging procedures done before,
during, and after radiotherapy may help doctors plan the best treatment.

Study Design

Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans, dual CBCT up to 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans, 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans, and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART.

Primary Outcomes

Differences of calculated set up and tissue-motion errors of 2 mm between the different imaging technologies

time frame:
up to 7 weeks

Dose variation between the different imaging technologies for normal tissue structures of 10%

time frame:
Up to 7 weeks

Greater than or equal to 5% variation of normal tissue toxicity

time frame:
Up to 7 weeks

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria:
- Histologic or cytologic confirmation of head and neck malignancy
- Patients who will be treated with definitive radiation therapy or concurrent
chemoradiation therapy
- Gross tumor volume (GTV) must be visible on CT
- All patients must be informed of the investigational nature of this study and must
give written informed consent in accordance with institutional and federal guidelines
Exclusion Criteria:
- Pregnant or nursing women may not participate; women of reproductive potential must
be offered a pre-treatment pregnancy test and informed of the need to practice an
effective contraceptive method
- Prior treatment with radiation therapy to the head and neck
- Serum creatinine > 1.5 and/or
- Blood urea nitrogen [BUN] > 25
- Treatment with any prior chemotherapy or surgery (excluding diagnostic biopsy) for
this malignancy
- Patients with known syndromes expected to alter radiosensitivity (e.g.
ataxia-telangiectasia, scleroderma, lupus, human immunodeficiency virus
[HIV]/acquired immunodeficiency deficiency syndrome [AIDS]) may not participate

Additional Information

I. To conduct a clinical imaging study utilizing three novel in-room imaging systems:
Oblique Brainlab ExacTrac images, Orthogonal Varian kilovoltage (kV) On-board Imaging (OBI)
image, and Varian cone-beam computed tomography (CBCT) imaging to assess their performance
in reducing inter- and intrafractional setup errors, relative to weekly megavoltage (MV)
electronic portal imaging device (EPID) images, using both bony landmarks and soft tissue
changes for head and neck cancer (HNC) patients undergoing external beam radiation therapy
(RT).
II. To assess the accuracy of CBCT imaging for measuring systematic soft tissue changes in
the head and neck (HN) area relative to conventional high resolution contrast enhanced
fan-beam computed tomography (CT) (FBCT) as a standard.
III. To assess the systematic and random soft tissue motion errors using daily CBCT imaging
relative to bony-landmark alignment to evaluate the benefit of soft tissue imaging during
radiotherapy.
IV. To quantify soft tissue changes during an entire course of radiotherapy (e.g. tumor
shrinkage) using daily CBCT imaging.
V. To determine the feasibility of using measured set up and soft-tissue motion
uncertainties in conjunction with volume changes observed on serial CBCT images, for offline
adaptive replanning of HNC patients using available planning tools.
VI. To quantify the benefits of adaptive image-guided radiotherapy (IGRT) in HN patients in
terms of target coverage and normal tissue avoidance.
VII. To determine the feasibility of mounting a phase I/II trial to assess the clinical
benefits of image-guided adaptive radiotherapy (IGART) in terms of acute and late toxicities
and tumor control.
VIII. To build a HNC patient database for future validation of IGART processes using
deformable image registration and Virtual Clinical Trials (VCTs).
OUTLINE:
Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans, dual
CBCT up to 5 times weekly for a total of 33-35 scans, 2-dimensional (2-D) x-ray with Varian
kV OBI 5 times weekly for a total of 33-35 scans, 2-D x-ray with Brain Lab ExacTrac 5 times
weekly for a total of 33-35 scans, 2-D x-ray with Varian MV OBI once weekly for a total of
6-7 scans, and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing
IGART.

Trial information was received from ClinicalTrials.gov and was last updated in October 2015.